ISO 5834-2-2011 pdf download.Implants for surgery一Ultra-high- molecular-weight polyethylene一 Part 2: Moulded forms.
7.3 Ash
Th. ash shea be measured In ardano. with ISO 3451.1 2008. method A. p.r1ornng dl4lcate tests on each of two test spcimens — (700 50) C, The mien of The esiAts on the two test specimens shat be less Than the vakie given ii Table 1.
7.4 TensIle stress at yleld
The tenste stress at yve. tL,. shall be det.mwied by th tensile bit speciSed m ISO 527-I, using an .xlerwom.I.r to measure th seam and eppfying a test speed of (100*10) ,nmlm’n At least lIve test specanens of ttickness (1.5 ± 0.5) nwn shal be tested The meat, of the rests on the lIve test specimens shaM not be less than the v,es given m Table 1.
7.5 TensIle stress at break
The tense sbess break. n. shall be measured dumg the test descnbed in 7.4 The mean of the results on the five test specimens shall not be less than the values ven in Table 1.
7.6 ElongatIon at break
Th e4ontior, at break. . shall be measured dunog the test desad in 7.4 The mean of the results on the five test specimens shal not be less than the values giren in Table 1.
7.7 Notched Impact strength
The dob..notclved impact strength, aCN. shall be determined by the Impeci test spcdted in either ISO 11542-21996, Annex B (Charpy) or ASW F648:2007 (lzod)
In cc,. of dt or spute. The test method sp.clfied it ISO 11542-2 shall be used as the referenc, method.
7.8 Sample area for extraneous matter
A total rnactened surface area 01(500. 1O) rnn2 shaM be taken Iron, locations wihin the fafncaled form. The area exatmned shal Include both transverse and longetucbial samples, or C may be produced by repeated sectioning througti th. thickness of the labnc.ted form,
8 IdentIfication marking
Each Cern suppled shall be identiited with at least a lot eNifIcation A nwkwig. which can also be a serial identrficakon, wah reference to the lot ldentW.callon. may be repeated at intervals along The length 01 the item
9 Test certificate
Each lot shall be suppbed with a test certificate stateig the results of The lasts oonc5jcl.d and cootormance with the r.quwem.nts of the part of ISO 5834 The test certificat, shall includ, the Polloweig rformabon
a) reference to this part of ISO 5834. i.e ISO 5834-a2011;
b) statementofmaterisltype,l.e.TypelorType2orType3;
C) lot nurmtier or serte number with reference SO the lot number
d) number of items;
a) last values ri accordanc, with the isppropnate clsuaes of the part of ISO 5834,
f) desaipeon of the UI-IMWPE annealing treatment as agreed by the purctiaser and the vendor.ISO 5834-2 pdf download.